Computed Tomography X-ray System; Model uCT 760; Rx; UDI: (01) GTIN: 06971576831043 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular).
The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
US Nationwide distribution including in the states of CA, IN and TX. See uploaded distribution list for more details.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2703-2020